Core Insights - GSK plc announced that the European Medicines Agency has accepted its marketing authorization application for linerixibat, an investigational IBAT inhibitor, aimed at treating cholestatic pruritus in patients with primary biliary cholangitis [1][7] - The MAA for linerixibat is based on positive results from the phase III GLISTEN study, which demonstrated significant improvement in symptoms compared to placebo [4][7] - GSK aims for linerixibat to be the first approved therapy for itch associated with PBC, addressing a significant unmet medical need in the market [5][6] Company Developments - A regulatory filing for linerixibat is under review in the United States, with a final FDA decision expected on March 24, 2026 [2] - Year-to-date, GSK's shares have increased by 13.1%, contrasting with a 3.3% decline in the industry [2] Competitive Landscape - The PBC treatment market is seeing increased competition, with other companies like Gilead Sciences and Mirum Pharmaceuticals developing their own therapies [6][8][9] - Gilead's seladelpar received accelerated approval from the FDA and conditional marketing authorization from the European Commission for PBC treatment [8] - Mirum is currently evaluating volixibat in a phase IIb study, with enrollment expected to complete in 2026 [9]

Core Insights - GSK's new drug application for linerixibat has been accepted by the FDA for review, with a decision expected on March 24, 2026 [1][7] - If approved, linerixibat could fulfill a significant unmet medical need for patients suffering from cholestatic pruritus associated with primary biliary cholangitis (PBC) [2][5] GSK's Drug Development - The NDA for linerixibat is based on positive results from the phase III GLISTEN study, which demonstrated significant improvement in cholestatic pruritus and related sleep interference compared to placebo [4][7] - Cholestatic pruritus is a common symptom of PBC, a rare autoimmune disease that can lead to liver failure [5] Competitive Landscape - Other companies are also pursuing treatments for PBC, including Gilead Sciences, which received accelerated approval for seladelpar in August 2024 [8] - Seladelpar was acquired by Gilead for $4.3 billion and is now part of their liver disease portfolio [9] - Mirum Pharmaceuticals is developing volixibat, another oral IBAT inhibitor, currently in phase IIb trials [9]